The IRB Ecosystem of a Busy Clinical Research Institution

Transcription

1 The IRB Ecosystem of a Busy Clinical Research Institution HCCA Compliance Institute / April 21, 2015 Orlando, FL Charles Eibeler, Director, Business Development Stuart Horowitz, PhD MBA, President, Institutions & Institutional Services 1

2 Agenda The IRBs and your HRPP What is an IRB Ecosystem? Why & when an IRB Ecosystem? How to work with outside IRBs Human Research Protection Program (HRPP) A shared responsibility 2

3 An HRPP is a shared responsibility Institution IRBs Investigators Components of the HRPP Employees Legal counsel IRB Grants and Contracts Office IRB IRBs IRB Investigators and research staff 3

4 Authorities IRB Approve research Modify research Disapprove research Suspend research Terminate research Observe research Acts on research Institution Disapprove research Non compliance Select IRBs Restrict investigators Hire/fire staff Allocate funds Acts on individuals and systems IRB Ecosystem A set of co-existing, human research review units integrated with an institution s HRPP. Based on trust Efficient, with non-duplicative activities Partners in human research protections Open communication Honesty Single-minded focus Integrated with institution s HRPP 4

5 Simple IRB Ecosystem Captive IRB NCI CIRB HRPP NeuroNext or StrokeNet Independent IRB Partners in Human Research Protections 5

6 Teammates in Overcoming Obstacles Why Rely on Outside IRBs? By requirement: Sponsor Funding Agency 6

7 Why Rely on Outside IRBs? Continued By Choice: Captive IRB workload Multi-campus institution wants to consolidate IRBs Desire to focus on IIR Desire for more clinical trials Changing Landscape of Clinical Research 7

8 Serious decline in federal research dollars for US institutions Pharma: Urgent Need To Change FDA Approved Drugs Global Pharma R&D Budget ($bn) $160 $147 $140 $120 $100 $1,900 Total Cost Per New Drug ($mm) 90% of R&D $1,900 expenditures result in NO new $1,300 drug approvals $ $ $80 $60 $40 $20 $0 $100 $

9 Globally dispersed clinical trial activity Offshoring means fewer activities for US investigators North America Western Europe Emerging Regions 7% 9% 14% 14% 21% 16% 29% 26% 12% 13% 84% 72% 63% 59% 61% Source: Tufts CSDD Global research snapshot & forecast Chris Toller, Clinical Studies in Asia Pacific: A Regional Perspective. J. Clin Studies Vol 5;3. pp

10 In an environment of research budget cuts, can clinical trials provide alternate research funding opportunities? Time for a change From CenterWatch December

11 When? 11

12 How to work with outside IRBs Decision-making 12

13 Choosing IRB Partner(s) Some may be chosen for you NCI-CIRB Novartis Signature StrokeNet, etc Choosing IRB Partner(s) continued You get to choose others Your needs Your desires Your expectations Your limitations 13

14 Careful Transition Management Key Issues to Manage Regulatory notifications/filing Communication Internal stakeholders External stakeholders Integration with institutional workflows & eirb software Policy adjustments Informed consent templates Gatekeepers Costs & invoicing 14

15 Key Issues to Manage continued Contract or MSA Required by IRB? Required by institution? Terms & conditions? Single point of contact Performance expectations Redacted minutes Reports Management of noncompliance Ongoing Relationship Management 15

16 Thank You! For more information please us at: 16